Resumen

El propósito de este estudio es determinar si un medicamento llamado spesolimab ayuda a las personas con pioderma gangrenoso (PG). El objetivo principal es evaluar si spesolimab conduce al cierre de las úlceras de PG. Este estudio está abierto a adultos con PG ulcerativo con al menos 1 úlcera que mida entre 5 cm² y 80 cm². Este estudio tiene 2 partes. En la Parte 1, los participantes son asignados a grupos de manera aleatoria, es decir, por azar. Un grupo recibe spesolimab y el otro grupo recibe placebo. Las infusiones de placebo tienen el mismo aspecto que las infusiones de spesolimab, pero no contienen ningún medicamento. Cada participante tiene 2 de 3 posibilidades de recibir spesolimab. Durante las primeras 8 semanas, los participantes también toman corticosteroides por vía oral. En la Parte 2, los participantes son asignados nuevamente a grupos. Los participantes sin úlceras abiertas tienen igual probabilidad de recibir spesolimab o placebo. Los participantes con úlceras cutáneas abiertas recibirán spesolimab. En ambas partes, los participantes reciben spesolimab o placebo en infusión intravenosa cada 4 semanas. Los participantes permanecen en el estudio durante aproximadamente 1,5 años. Durante este tiempo, realizan 20 visitas al sitio del estudio. En las visitas del estudio, los médicos examinan la piel del participante en busca de signos de PG. Los médicos también controlan regularmente la salud de los participantes y registran cualquier efecto no deseado. Los resultados de los grupos se comparan para evaluar si el tratamiento es eficaz.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.
Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
A confirmed diagnosis of ulcerative pyoderma gangrenosum (PG) (≥10 points on the PARACELSUS score) that requires systemic therapy in the opinion of the investigator. The diagnosis needs to be confirmed by an Adjudication Committee. Trial participants with mixed PG subtypes are eligible as long as the target lesion is of the ulcerative subtype.
At least one measurable (defined as measuring ≥5 cm\^2) PG ulcer. In trial participants with more than one PG ulcer, the target PG ulcer will be selected by the investigator and confirmed by external Adjudication Committee.
At the time of the Screening Visit, a maximum duration of 6 months since the target ulcer in the current PG episode was diagnosed. Target ulcers \>6 months since diagnosis are allowed if they are active and progressing, as judged by the investigator and confirmed by an Adjudication Committee.
Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information and in the protocol.

Criterios de exclusión

Trial participants with non-PG lesions.
Trial participants with a target PG ulcer measuring \>80 cm\^2.
Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee.
Presence of active ulcer infection at the Screening Visit (unless treated and resolved prior to administration of the first dose of trial medication) based on investigator assessment.
Presence of persistent or recurring bacterial infection requiring systemic antibiotic therapy; or clinically significant viral, fungal, or parasitic infections within 2 weeks prior to the Screening Visit. Any such infection must be resolved, with treatment completed ≥2 weeks prior to the Screening Visit. No new/recurrent infections should have occurred prior to Visit 2.
"Active or latent tuberculosis (TB)
Participants with active TB are excluded
Participants with latent TB may be included if treatment of latent TB, as per local guidelines, is initiated prior to randomization and completed during the course of the trial."
Chronic or acute infections including Human immunodeficiency virus (HIV) infections and viral hepatitis (including occult hepatitis); the corresponding laboratory tests will be performed during screening. A trial participant can be re-screened if the trial participant was treated and is cured from the acute infection.
Severe, progressive, or uncontrolled hepatic disease, defined as \>3x Upper Limit of Normal (ULN) elevation in Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) or alkaline phosphatase, or \>2x ULN elevation in total bilirubin.

Ensayo multicéntrico, aleatorizado, controlado con placebo, doble ciego y de grupos paralelos para evaluar la seguridad y eficacia de spesolimab (BI 655130) en pacientes adultos con pioderma gangrenoso (PG) ulcerativo que requieren terapia sistémica

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Spesolimab

Placebo matching to spesolimab

Prednisone

Prednisolone

Ubicaciones

CIPREC

Hospital Italiano de Buenos Aires

Instituto de Especialidades de la Salud Rosario

Patrocinadores

Contactos

Boehringer Ingelheim